Effect of a Myopia Control Lens on the Astigmatism in Children

A Monocentre, Single-Arm Trial to Study the Effect of Lens Inspired by Myopia Control Solutions on the Astigmatism of a Child

The goal of this clinical trial is to investigate over a one-year period the effect of myopia control spectacle lenses on astigmatism in children aged 6 to 13 years with myopia and astigmatism.

The main question it aims to answer is:

- How does the eye respond at each timepoint to the myopia control lenses?

By evaluating: the change in astigmatism (cylinder) after one year?

Participants will:

Wear the assigned study spectacles daily

Visit the Essilor R&D Centre for scheduled follow-up sessions

Inclusion Criteria:

• Volunteer participant

• Informed consent of parent or guardian and assent of participant

• Age equal to or greater than 6 years and less than 13 years (before 13th birthday) at the time of consent.

• Refractive error (manifest refraction):

  • With the rule astigmatism (defined as vertical meridian has steeper curvature, Astigmatism prescribing axis in between: 0 to 34° and 146 to 180°)
  • Astigmatism should be more than or equal to 1.50D
  • Least myopic meridian equal or less than -0.50D
  • Most myopic meridian equal or greater than -5.50D.
  • Anisometropia should be less than or equal to 1.00D

• Best corrected visual acuity: Better than 0.2 logMAR in each eye

• Willingness and ability to:

  • participate in trial for at least 12 months.
  • attend scheduled visits.
  • not to be involved in other myopia control treatments concurrently.

• No history of any myopia control interventions (i.e., myopia control spectacle lenses, myopia control contact lenses, orthokeratology lenses or atropine, etc.)

Exclusion Criteria:

• History or presence of:

  • An ocular disease
  • Strabismus
  • Amblyopia